Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.

Key facts

Study ID

NCT00658554

Run by

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

People needed

24

Starts

2008-04-01

Expected to finish

2008-06-01

Last updated by the study team

2008-06-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject must provide written informed consent prior to any study related procedures
• Subjects must be between the ages of 18 and 65 years
• Male participants must have been surgically sterilized
• Female participants must have been surgically sterilized or be post menopausal and must have a negative serum pregnancy test
• All participants will be phenotypically extensive metabolizers based on their CYP C19 genotype.

You may not qualify if…

• Males who are not surgically sterilized
• Females of child-bearing potential who are not surgically sterilized
• Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
• Any clinically significant abnormality in the screening laboratory tests or ECG
• Received any investigational drugs within four weeks
• Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Where it is running

• Covance Clinical Research Unit, Inc. — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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